BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 21025424 · Received December 27, 2024

    Report

    Report Number
    2249723-2024-0005289
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Report Date
    April 21, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9,G1 (CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H3, H6 ( TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) LISTED THE PARTS NEED TO BE REPLACED UPPER DISPLAY (0997-00-1181), X2 HINGE COVER (0380-00-0561), HINGE RIGHT 0105-00-0138-02) AND HINGE LEFT (0105-00-0138-01). PATIENT INVOLVEMENT UNKNOWN AND HARM DETAILS UNKNOWN. AFTER DOING 3 GOOD FAITH EFFORTS (GFE'S) WE HAVEN'T RECEIVED ANY INFORMATION. AS OF NOW, THE INVESTIGATION IS CLOSED, IF ANY NEW INFORMATION IS RECEIVED FUTURE RELATED TO PART REPLACEMENT WILL REOPEN THE COMPLAINT AND UPDATE IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISPLAY AND HINGE COVER OF CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) IS IN POOR CONDITION AND WILL REQUIRE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975932 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown